원문정보
Study on the ASEAN Harmonization System of Pharmaceutical Products for Export of Domestic Medicines into Southeast Asian Countries
초록
영어
BACKGROUND(OBJECTIVE) Association of South-East Asian Nations (ASEAN) has been emerged as the main export region of pharmaceutical products. Therefore, the cooperation with member countries of ASEAN has been emphasized and, it is necessary to understand ASEAN pharmaceutical regulatory guidelines for the growth of the pharmaceutical industry. METHODS This study investigated the regulatory guidelines adopted by ASEAN through the search of homepage, internet articles, and various regulatory information. RESULTS The main contents of ASEAN Common Technical Dossiers (ACTD) and ASEAN Common Technical Requirements (ACTR) published were presented. They were implemented by all members of ASEAN countries even though there was a slight difference in implementation timing and content. The differences as well as common features of regulatory guidelines among ASEAN member countries were presented. Detail description on regulatory agency, certificate of a pharmaceutical product (CPP), product labelling, and official product approval timelines were also described. International pharmacopoeia such as USP, BP, EP, and JP were legally recognized in ASEAN. Pharmacovigilance and risk management plans in ASEAN followed the ICH guidelines without specific requirements. The cooperation on regulatory harmonization has been continued. Especially joint assessment procedure, formal procedure including simultaneous marketing authorization application to ASEAN member countries and joint assessment reports, will be implemented in the near future. CONCLUSION Understanding and monitoring for ASEAN regulatory guideline will help make the export of domestic pharmaceutical products to the ASEAN region faster and more efficient.
목차
서론
연구방법
연구결과
1. 조직
2. 의약품 기술 문서 및 가이드라인
3. 개발 중인 문서
4. ASEAN의 의약품 허가제도 조화를 위한 지원 프로젝트
5. 기타 특이점
고찰
결론
감사의 말씀
참고문헌